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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000206
Receipt No. R000000250
Scientific Title Multicenter study of a randomized controlled trial with or without maintenance/intensification therapy in patients with previously untreated acute promyelocytic leukemia (JALSG APL97 study)
Date of disclosure of the study information 2005/09/14
Last modified on 2012/12/21

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Basic information
Public title Multicenter study of a randomized controlled trial with or without maintenance/intensification therapy in patients with previously untreated acute promyelocytic leukemia (JALSG APL97 study)
Acronym Randomized trial with or without maintenance/intensification therapy in patients with acute promyelocytic leukemia (JALSG APL97 study)
Scientific Title Multicenter study of a randomized controlled trial with or without maintenance/intensification therapy in patients with previously untreated acute promyelocytic leukemia (JALSG APL97 study)
Scientific Title:Acronym Randomized trial with or without maintenance/intensification therapy in patients with acute promyelocytic leukemia (JALSG APL97 study)
Region
Japan

Condition
Condition acute promyelocytic leukemia (APL)
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Differentiation therapy of acute promyelocytic leukemia (APL) with all-trans retinoic acid (ATRA) followed by intensive chemotherapy has shown significant improvement of event-free survival in patients with APL. After consolidation therapy, the maintenance/intensification therapy has been given based on the previous results of the Japan Adult leukemia Study Group (JALSG) AML87 study, in which patients receiving the longer maintenance/intensification therapy showed significantly better relapse-free survival (RFS). If short-term treatment without maintenance/intensification therapy shows identical RFS rates as compared with long-term therapy, it would be of benefit to quality of life in the patients and medical costs. With this concern, the JALSG has planned a prospective randomized controlled trial comparing observation and 6 courses of maintenance/intensification therapy for APL patients who are negative PML-RARa at the end of 3 courses of consolidation therapy.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes relapse-free survival at 5 years
Key secondary outcomes overall survival at 5 years, complete remission rate, event-free survival at 5 years, efficacy of detection of PML-RARalpha

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 6 courses of maintenance/intencification therapy consisting of enocitabine, daunorubicin, mercaptopurine, mitoxantrone, etoposide, vindesine, and aclarubicin
Interventions/Control_2 no maintenance/intensification therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. Previously untreated APL
2. Age between 15 and 70 years
3. Performance status between 0 and 3 (ECOG criteria)
4. Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL), kidneys (serum creatinine level < 2.0 mg/dL), lung (PaO2 > 60 mmHg or SpO2 > 93%) and heart (no severe abnormalities detected on electrocardiograms)
5. Written informed consent to participate the trial
Key exclusion criteria 1. Uncontrolled active infection
2. Past history of myocardial infarction or cardiac failure
3. Past history of renal failure
4. Uncontrolled diabetes mellitus
5. Liver cirrhosis
6. Leukemic involvement in the CNS
7. Another severe and/or life threatening disease
8. Pregnant and/or lactating woman
9. Positive for HIV antibody test
Target sample size 234

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuzo Ohno
Organization Aichi Cancer Center
Division name Honor Director
Zip code
Address 1-1 Kakodono, Chigusa, Nagoya 464-8681, Japan
TEL 052-762-6111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norio Asou
Organization Kumamoto University School of Medicine
Division name Department of Hematology
Zip code
Address 1-1-1 Honjo, Kumamoto, Kumamoto 860-8556, Japan
TEL 096-373-5156
Homepage URL
Email ktcnasou@gpo.kumamoto-u.ac.jp

Sponsor
Institute Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 日本大学医学部血液膠原病内科、東京都立駒込病院内科・血液内科、名古屋大学医学部第一内科、岡崎市民病院内科、大同病院、豊橋市民病院血液内科、一宮市立市民病院、名古屋大学医学部難治感染症部、愛知県がんセンター血液化学療法部、名古屋第一赤十字病院内科、藤田保健衛生大学医学部内科、三重大学医学部血液内科、三重厚生連鈴鹿中央総合病院、鈴鹿回生総合病院内科、松坂市民病院、山田赤十字病院、武内病院、近畿大学医学部血液・腎臓・膠原病内科、大阪府立成人病センター第五内科、長崎大学医学部原研内科、佐世保市立総合病院、熊本大学医学部第二内科、NTT西日本九州病院血液免疫内科、自治医科大学血液学、国立療養所南岡山病院、国立病院岡山医療センター、公立学校共済組合中国中央病院、群馬大学医学部第三内科、群馬県立がんセンター血液内科、国立療養所西群馬病院、公立藤岡総合病院、福井大学医学部第一内科、倉敷中央病院、国立がんセンター、埼玉医科大学第一内科、兵庫医科大学第二内科、国立大阪病院、川崎医科大学血液内科、高知県・高知市病院企業団立高地医療センター、千葉大学医学部第二内科、千葉市立青葉病院内科、奈良県立医科大学呼吸器感染症血液内科、東京慈恵会医科大学血液・腫瘍内科、獨協医科大学血液内科、国立名古屋病院血液センター、亀田総合血液腫瘍内科、太田西ノ内病院血液疾患センター、高知大学医学部血液・呼吸器内科、滋賀医科大学第二内科、社会保険滋賀病院内科、国立がんセンター東病院内科、安城更生病院、聖マリアンナ医科大学血液腫瘍内科、聖マリアンナ医科大学横浜西部病院血液腫瘍内科、京都府立医科大学医科大学第二内科、公立南丹病院内科、信州大学医学部第二内科、東京女子医科大学血液内科、浜松医科大学第三内科、焼津市立総合病院、浜松医療センター血液科、袋井市立袋井市民病院内科、鹿児島大学第一内科、今村病院本院、栃木県立がんセンター、金沢大学医学部第三内科、東京医科大学第一内科、杏林大学医学部第二内科、北海道大学医学部血液内科、函館中央病院、関西医科大学第一内科、済生会前橋病院血液内科、東海大学医学部血液リウマチ内科、海老名総合病院、山口大学医学部第三内科、山口県立中央病院、若弘会病院、大阪大学医学部第三内科、日生病院第三内科、東京大学医学部血液腫瘍内科、新潟大学医学部第一内科、大分県立病院血液内科、国立病院九州がんセンター造血器科、帝京大学医学部内科、帝京大学医学部附属市原病院、愛知医科大学第二内科、北里大学医学部第三内科(東京都立墨東病院)、山形大学医学部第三内科、札幌北楡病院内科、青森県立中央病院リウマチ血液内科、兵庫県立成人病センター血液内科、京都府立医科大学第三内科、大阪市立総合医療センター、防衛医科大学校第三内科、秋田大学医学部第三内科

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.jalsg.jp/04/02.html
Number of participants that the trial has enrolled
Results
1) Of the 302 registered, 283 patients were assessable and 267 (94%) achieved complete remission (CR).
2) A total of 175 patients negative for PML-RARalpha at the end of consolidation were randomly assigned to receive either intensified maintenance chemotherapy (n = 89) or observation (n = 86).
3) Predicted 6-year DFS was 79.8% for the observation group and 63.1% for the
chemotherapy group, showing no statistically significant difference between the two groups (P = 0.20).
4) Predicted 6-year survival of patients assigned to the observation was
98.8%, which was significantly higher than 86.2% in those allocated to the intensified maintenance (P = 0.014).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
1997 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
1997 Year 05 Month 01 Day
Last follow-up date
2008 Year 06 Month 01 Day
Date of closure to data entry
2009 Year 06 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information 1. Asou N, Kishimoto Y, Kiyoi H, Okada M, Kawai Y, Tsuzuki M, Horikawa K, Matsuda M, Shinagawa K, Kobayashi T, Ohtake S, Nishimura M, Takahashi M, Yagasaki F, Takeshita A, Kimura Y, Iwanaga M, Naoe T, Ohno R. A randomized study with or without intensified maintenance chemotherapy in patients with acute promyelocytic leukemia who have become negative for PML-RARalpha transcript after consolidation therapy: The Japan Adult Leukemia Study Group (JALSG) APL97 study. Blood 2007;110:59-66.

2. Yanada M, Matsushita T, Asou N, Kishimoto Y, Tsuzuki M, Maeda Y, Horikawa K, Okada M, Ohtake S, Yagasaki F, Matsumoto T, Kimura Y, Shinagawa K, Iwanaga M, Miyazaki Y, Ohno R, Naoe T. Severe hemorrhagic complications during remission induction therapy for acute promyelocytic leukemia: incidence, risk factors, and influence on outcome. Eur J Haematol. 2007;78(3):213-219.

3. Ono T, Takeshita A, Iwanaga M, Asou N, Naoe T, Ohno R; Japan Adult Leukemia Study Group. Impact of additional chromosomal abnormalities in patients with acute promyelocytic leukemia: 10-year results of the Japan Adult Leukemia Study Group APL97 study. Haematologica. 2011;96(1):174-176.

4.Ono T, Takeshita A, Kishimoto Y, Kiyoi H, Okada M, Yamauchi T, Tsuzuki M, Horikawa K, Matsuda M, Shinagawa K, Monma F, Ohtake S, Nakaseko C, Takahashi M, Kimura Y, Iwanaga M, Asou N, Naoe T; the Japan Adult Leukemia Study Group. Long-term outcome and prognostic factors of elderly patients with acute promyelocytic leukemia. Cancer Sci 2012;103:1974-1978.

Management information
Registered date
2005 Year 09 Month 13 Day
Last modified on
2012 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000250

Research Plan
Registered date File name

Research case data specifications
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Research case data
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